Quality Control Outsource Coordinator

Quality Control Outsource Coordinator

The Netherlands, 1-year contract, 36h-40h, Hybrid way of work 

Johnson & Johnson Worksense is responsible for finding, engaging, and contracting talent for the Johnson & Johnson contingent workforce.

We are currently recruiting a Quality Control Outsource Coordinator to join our contingent workforce on a growing team in Janssen Biologics in Leiden for an initial 12-month contract. 

The Leiden QC department is responsible for raw material, in-process, and release testing for products manufactured at the site. Additionally, the Leiden QC department has a unique global responsibility and exposure by being the stability testing hub for large molecule products within Janssen Supply Chain, and by partnering with multiple CMOs to perform the release testing. The department is structured in different testing laboratories and supporting teams, which are divided based on specific techniques and/or expertise. All test laboratories are supported by the Release & Stability team, which is integrated by product QC owners who lead and coordinate the release and stability testing processes for commercial products through deep expertise and effective communication between global stakeholders and Leiden QC. 

Currently, the Release & Stability team consists of 14 people, and due to the expansion of workload, we are looking for a new employee to set up and coordinate the External Contract Lab governance structure.  

In this role, you will combine your experience in quality control testing with your talent for keeping clear overviews and coordination skills to ensure all required assets are in place to enable efficient outsourcing and testing of our products. In this team, you will work closely together with the Release & Stability product coordinators, who are responsible for the on-time testing. 

You as a Quality Control Outsource Coordinator will be responsible for:

• Set up and coordinate a governance structure with ECLs
• Acting as subject matter expert (end-to-end) on outsourcing assays that cannot be performed in-house at Leiden 
•  Responsible for day-t0-day quality and business activities at External Contract labs, including quality investigations, change control management, quality agreements, etc.
•  Work closely together with External Quality related to selection and approval of External Contract Laboratories
• Participates in (bi)-weekly meetings with external labs to ensure a flawless experience
• Keeping a clear overview of outstanding tests by using reporting tools
• Prepare and/or approve documents and invoices to ensure timely testing and payment of external parties
• Ensure timely testing of ECLs in line with QC customers’s expectations, including routinely monitor and follow up with ECLs
• Leads and drives continuous improvement projects. 
• Adhere to compliance best practices, regulations, and lean principles. 
• Perform other work-related activities assigned by supervisor. 
• Maintain compliance with all company policies and procedures

You as a Quality Control Outsource Coordinator have:

• Bachelor’s degree (or equivalent) in a relevant discipline with 2-4 years of related working experience in a GMP environment
• Excellent verbal and written communication skills, including the ability to effectively communicate with internal and external customers
• Didactical skills to effectively transfer information in a training environment. 
• Advanced knowledge of lab systems and lab environment, data integrity, and data management. 
• Ability to work independently
• Proactive stakeholder management
• Knowledge about the Outsourcing process within a pharmaceutical company is advantageous

If you meet our requirements and are interested in hearing more about our Quality Control Outsource Coordinator role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

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